Tranexamic Acid to Prevent Bleeding After Endoscopic Resection of Large Colorectal Polyps: A Pilot Project

Summary

Colorectal cancer is the second most common cancer in Canada. Colonoscopy and removal of precancerous polyps (polypectomy) reduces the incidence and mortality associated with colorectal cancer. However, polypectomy is associated with adverse events. Post-polypectomy bleeding has a significant impact on the life of the patient as it can require hospitalization, transfusions, repeat colonoscopy and rarely death. It is also a substantial cost to the health care system. There currently is no standard of care to prevent bleeding after polypectomy. Tranexamic acid reduces fibrinolysis by slowing down the conversion of plasminogen to plasmin which may prevent bleeding. Although this medication is used extensively for other purposes, it has not been studied before to prevent post-polypectomy bleeding. This pilot study will examine factors involved in the feasibility of conducting a large-scale randomized controlled trial (RCT). This pilot study will include 25 consecutive patients who are treated with tranexamic acid after endoscopic mucosal resection (EMR) of large non-pedunculated colorectal polyps (LNPCP's) to prevent PPDB.

Timeline

Start

2020-09-10

Primary completion

2021-10-10

Completion

2023-04-01

Publications

• Results Nishihara R, Wu K, Lochhead P, Morikawa T, Liao X, Qian ZR, Inamura K, Kim SA, Kuchiba A, Yamauchi M, Imamura Y, Willett WC, Rosner BA, Fuchs CS, Giovannucci E, Ogino S, Chan AT. Long-term colorectal-cancer incidence and mortality after lower endoscopy. N Engl J Med. 2013 Sep 19;369(12):1095-105. doi: 10.1056/NEJMoa1301969.
• Results ASGE Standards of Practice Committee; Fisher DA, Maple JT, Ben-Menachem T, Cash BD, Decker GA, Early DS, Evans JA, Fanelli RD, Fukami N, Hwang JH, Jain R, Jue TL, Khan KM, Malpas PM, Sharaf RN, Shergill AK, Dominitz JA. Complications of colonoscopy. Gastrointest Endosc. 2011 Oct;74(4):745-52. doi: 10.1016/j.gie.2011.07.025. No abstract available.
• Results Albeniz E, Fraile M, Ibanez B, Alonso-Aguirre P, Martinez-Ares D, Soto S, Gargallo CJ, Ramos Zabala F, Alvarez MA, Rodriguez-Sanchez J, Mugica F, Nogales O, Herreros de Tejada A, Redondo E, Pin N, Leon-Brito H, Pardeiro R, Lopez-Roses L, Rodriguez-Tellez M, Jimenez A, Martinez-Alcala F, Garcia O, de la Pena J, Ono A, Alberca de Las Parras F, Pellise M, Rivero L, Saperas E, Perez-Roldan F, Pueyo Royo A, Eguaras Ros J, Zuniga Ripa A, Concepcion-Martin M, Huelin-Alvarez P, Colan-Hernandez J, Cubiella J, Remedios D, Bessa I Caserras X, Lopez-Viedma B, Cobian J, Gonzalez-Haba M, Santiago J, Martinez-Cara JG, Valdivielso E, Guarner-Argente C; Endoscopic Mucosal Resection Endoscopic Spanish Society Group. A Scoring System to Determine Risk of Delayed Bleeding After Endoscopic Mucosal Resection of Large Colorectal Lesions. Clin Gastroenterol Hepatol. 2016 Aug;14(8):1140-7. doi: 10.1016/j.cgh.2016.03.021. Epub 2016 Mar 24.
• Results Pohl H, Grimm IS, Moyer MT, Hasan MK, Pleskow D, Elmunzer BJ, Khashab MA, Sanaei O, Al-Kawas FH, Gordon SR, Mathew A, Levenick JM, Aslanian HR, Antaki F, von Renteln D, Crockett SD, Rastogi A, Gill JA, Law RJ, Elias PA, Pellise M, Wallace MB, Mackenzie TA, Rex DK. Clip Closure Prevents Bleeding After Endoscopic Resection of Large Colon Polyps in a Randomized Trial. Gastroenterology. 2019 Oct;157(4):977-984.e3. doi: 10.1053/j.gastro.2019.03.019. Epub 2019 Mar 15.
• Results Feagins LA. Colonoscopy, Polypectomy, and the Risk of Bleeding. Med Clin North Am. 2019 Jan;103(1):125-135. doi: 10.1016/j.mcna.2018.08.003. Epub 2018 Nov 1.
• Results Hassan C, Repici A, Sharma P, Correale L, Zullo A, Bretthauer M, Senore C, Spada C, Bellisario C, Bhandari P, Rex DK. Efficacy and safety of endoscopic resection of large colorectal polyps: a systematic review and meta-analysis. Gut. 2016 May;65(5):806-20. doi: 10.1136/gutjnl-2014-308481. Epub 2015 Feb 13.
• Results Burgess NG, Metz AJ, Williams SJ, Singh R, Tam W, Hourigan LF, Zanati SA, Brown GJ, Sonson R, Bourke MJ. Risk factors for intraprocedural and clinically significant delayed bleeding after wide-field endoscopic mucosal resection of large colonic lesions. Clin Gastroenterol Hepatol. 2014 Apr;12(4):651-61.e1-3. doi: 10.1016/j.cgh.2013.09.049. Epub 2013 Oct 1.
• Results Forbes N, Frehlich L, James MT, Hilsden RJ, Kaplan GG, Wilson TA, Lorenzetti DL, Tate DJ, Bourke MJ, Heitman SJ. Routine Prophylactic Endoscopic Clipping Is Not Efficacious in the Prevention of Delayed Post-Polypectomy Bleeding: A Systematic Review and Meta-Analysis of Randomized Controlled Trials. J Can Assoc Gastroenterol. 2019 Aug;2(3):105-117. doi: 10.1093/jcag/gwy033. Epub 2018 Jul 20.
• Results Albeniz E, Alvarez MA, Espinos JC, Nogales O, Guarner C, Alonso P, Rodriguez-Tellez M, Herreros de Tejada A, Santiago J, Bustamante-Balen M, Rodriguez Sanchez J, Ramos-Zabala F, Valdivielso E, Martinez-Alcala F, Fraile M, Elosua A, Guerra Veloz MF, Ibanez Beroiz B, Capdevila F, Enguita-German M. Clip Closure After Resection of Large Colorectal Lesions With Substantial Risk of Bleeding. Gastroenterology. 2019 Nov;157(5):1213-1221.e4. doi: 10.1053/j.gastro.2019.07.037. Epub 2019 Jul 27.
• Results Roberts I, Shakur H, Coats T, Hunt B, Balogun E, Barnetson L, Cook L, Kawahara T, Perel P, Prieto-Merino D, Ramos M, Cairns J, Guerriero C. The CRASH-2 trial: a randomised controlled trial and economic evaluation of the effects of tranexamic acid on death, vascular occlusive events and transfusion requirement in bleeding trauma patients. Health Technol Assess. 2013 Mar;17(10):1-79. doi: 10.3310/hta17100.
• Results WOMAN Trial Collaborators. Effect of early tranexamic acid administration on mortality, hysterectomy, and other morbidities in women with post-partum haemorrhage (WOMAN): an international, randomised, double-blind, placebo-controlled trial. Lancet. 2017 May 27;389(10084):2105-2116. doi: 10.1016/S0140-6736(17)30638-4. Epub 2017 Apr 26.
• Results Bennett C, Klingenberg SL, Langholz E, Gluud LL. Tranexamic acid for upper gastrointestinal bleeding. Cochrane Database Syst Rev. 2014 Nov 21;2014(11):CD006640. doi: 10.1002/14651858.CD006640.pub3.
• Results Smith SR, Murray D, Pockney PG, Bendinelli C, Draganic BD, Carroll R. Tranexamic Acid for Lower GI Hemorrhage: A Randomized Placebo-Controlled Clinical Trial. Dis Colon Rectum. 2018 Jan;61(1):99-106. doi: 10.1097/DCR.0000000000000943.
• Results Grass F, Braafladt S, Alabbad J, Lovely JK, Kelley SR, Mathis KL, Huebner M, Larson DW. The effects of tranexamic acid on blood loss and transfusion rate in colorectal surgery. Am J Surg. 2019 Nov;218(5):876-880. doi: 10.1016/j.amjsurg.2019.03.013. Epub 2019 Mar 15.

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